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FDAnews Device Daily Bulletin

Saginaw Medical Services Lands Form 483 For Procedural, Record-Keeping Failures

Aug. 4, 2017

Saginaw Medical Services drew a Form 483 for the absence of quality and acceptance procedures as well as its failure to maintain device records.

The agency issued the form after a May inspection of the firm’s Saginaw, Mich., facility. According to investigators, the facility had no procedures or directions in place regarding its quality policy, management reviews or audits, and did not conduct regular audits. The company had completed several made-to-order wheelchair cushion jobs since the beginning of 2015, but had no documentation describing the production procedures.

The firm also failed to produce documentation of the acceptance activity for the cushions’ final fitting process or procedures for this activity, the agency said. Investigators found the firm’s complaint procedures did not include an evaluation process for whether a complaint is reportable as an MDR. It also lacked device master records or device history records for the cushions.

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